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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD ALARIS¿ SMARTSITE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

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BD ALARIS¿ SMARTSITE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20028E
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd alaris¿ smartsite¿ extension set filter did not filter out the air in the line while priming it.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "2- filter not filtering air when rn priming lines.".
 
Manufacturer Narrative
H6: investigation: no product or photo was returned by the customer.The customer complaint that the filter is not filtering air could not be verified due to the product not being returned for failure investigation.A device history record review for model 20028e lot number 21039640 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of air bubbles/air in line with lot #21039640 regarding item #20028e.
 
Event Description
It was reported that the bd alaris¿ smartsite¿ extension set filter did not filter out the air in the line while priming it.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "2- filter not filtering air when rn priming lines.".
 
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Brand Name
BD ALARIS¿ SMARTSITE¿ EXTENSION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12485655
MDR Text Key271914654
Report Number9616066-2021-52071
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/04/2024
Device Model Number20028E
Device Catalogue Number20028E
Device Lot Number21039640
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/20/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received09/21/2021
Supplement Dates FDA Received10/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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